FDA Adverse Event Injury Summary report: N

BRAINSWAY DEEP TMS FOR OCD

MDR report key: 12820507 · Received November 15, 2021

Report

Report Number: MW5105345
Event Type: Injury
Date Received: November 15, 2021
Date of Event: November 5, 2021
Report Date: November 11, 2021
Manufacturer: BRAINSWAY LTD.
Product Code: QCI
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: AZ, US
Reporter Occupation: PATIENT
Health Professional: *

Narratives

Description of Event or Problem · 0

SO I STARTED TREATMENT WITH THE DEEPTMS FOR OCD, AND I STARTED NOTICING THE ISSUES AFTER MY SECOND TREATMENT. WHEN I WENT INTO WORK AFTER MY SECOND TREATMENT I WAS EXTREMELY NAUSEOUS. I HAVE BEEN HAVING ISSUES WITH MY TYPING AND SPELLING, I ALSO HAVE HAD SHORT TERM MEMORY LOSS, I LOSE MY TRAIN OF THOUGHT, I CANT FORM MY WORDS CORRECTLY. THE SHORT TERM MEMORY LOSS AND FORGETTING WHAT I WAS GOING TO DO IS HORRIBLE. AND A FRIEND TOLD ME I SOUNDED MORE ANXIOUS THEN I EVER HAVE. I HAVE REACHED OUT TO BRAINSWAY TWICE AND THE SAME PERSON PICKED UP THE PHONE BOTH TIMES AND PROMISED I WOULD GET A CALL BACK. NO CALLS BACK. I ASKED THE SECOND TIME I CALLED WITH A DIFFERENT ISSUE ARE YOU REALLY GOING TO HAVE SOMEONE GET BACK TO ME. SHE SAID SHE WOULD HAVE THE BRAINSWAY REP FOR MY AREA CALL ME BACK. SHE EVEN SAID SHE SUBMITTED IT AS AN EMERGENCY REQUEST. I CALLED LAST FRIDAY AND IT IS GOING TO BE A WEEK TOMORROW AND I HAVE NEVER RECEIVED A CALL BACK. I WANTED TO TALK TO THEM BEFORE I WENT FOR MY TREATMENT MONDAY. AND SHE ASSURED ME I MIGHT NOT GET THE CALL BACK BUT THAT I WOULD HEAR FROM SOMEONE. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1707206	BRAINSWAY DEEP TMS FOR OCD	TRANSCRANIAL MAGNETIC STIMULATION SYSTEM FOR OBSESSIVE-COMPULSIVE DISORDER	QCI	BRAINSWAY LTD.

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female